Pazopanib, Docetaxel, Prednisone Prostate

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary purpose is to define the safety and tolerability of docetaxel/prednisone in combination with pazopanib (DPP) in men with metastatic Castration Resistant Prostate Cancer (mCRPC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel George, MD
• Collaborator: GlaxoSmithKline
• Treatments: Docetaxel; Prednisone

Criteria

Inclusion Criteria:

• Histologically confirmed carcinoma of the prostate. Histologic evidence may be confirmed through local or metastatic biopsy review. Non-adenocarcinomas are permitted.

• Radiographic evidence of metastatic disease; non-evaluable, bone only metastasis is permitted.

• Evidence of disease progression despite castrate levels of testosterone (<50 ng/dl).

• At the time of screening, at least 2 weeks since prior palliative radiation therapy and 4 weeks from major surgery, and resolution of all toxic effects of prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE); version 4.0 Grade < 1.

• Age >18 years

• Adequate laboratory parameters

• Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2

• Life expectancy greater than 3 months

• Written, signed and dated Institutional Review Board (IRB) approved informed consent form.

Exclusion Criteria:

• History of or active central nervous system metastases

• The use of immunologic, biologic, or hormonal therapies within 2 weeks of study entry.

• Major surgery, open biopsy, traumatic injury within 4 weeks of the screening visit

• Subjects who have not recovered from prior biopsy, surgery, traumatic injury, and/or radiation therapy.

• Previous treatment with docetaxel, including in the neo-adjuvant or adjuvant setting

• Presence of non-healing wound or ulcer

• Grade 3 or greater hemorrhage within the past month.

• Uncontrolled hypertension

• American Heart Association Class 2-4 heart disease or any history of congestive heart failure with an ejection fraction <40%, recent cardiovascular event (within 12 months) including unstable angina, any exertional angina, myocardial infarction, exertional or rest claudication, or stroke/Cerebral Vascular Event/Transient Ischemic Attack. Patients with known moderate to severe documented carotid or peripheral vascular disease are excluded. Angioplasty or stenting of coronary or peripheral arteries are exclusionary if within the past 12 months.

• Anticoagulation with warfarin (therapeutic doses of warfarin for catheter patency are permitted up to 2 mg/day). Low molecular weight heparin is permitted.

• Diabetes mellitus with glycosylated hemoglobin A1c (HbgA1c) > 8% despite therapy

• Subjects with active autoimmune disorder(s) being treated with systemic immunosuppressive agents within 4 weeks prior to the screening visit.

• Active infection(s), active antimicrobial therapy or serious intercurrent illness.

• Does not agree to use medically acceptable contraceptive methods while on study and for 3 months after the last dose of pazopanib.

• Any other major medical or psychiatric illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study, including inability to absorb oral medications.

• Known hypersensitivity to any of the components in the docetaxel infusion or other medical reasons for not being able to receive adequate premedication (for example, antihistamine or anti-inflammatory agents).

• CalculatedQT (QTc) interval on baseline EKG > 500milliseconds

• History or presence of nephrotic syndrome